Taiwan FDA registration 15e96fd8dfdd4483415f27e61923e55c

ICEN 100 Urine Chemistry Analyzer (Unsterilized)

TW: 愛肯100 尿液化學分析儀(未滅菌)
Taiwan flagTaiwan·Risk Class 1·IRIS DIAGNOSTICS, A DIVISION OF IRIS INTERNATIONAL, INC.·Registered Jan 17, 2018 – Jan 17, 2023Cancelled
Registration details
Analysis ID
15e96fd8dfdd4483415f27e61923e55c
Customs Code
DHA09401873004
Company information
Manufacturer Country
United States
Product details
Intended Use
Limited to the first level identification range of the "Automatic Urinalysis System (A.2900)" of the Measures for the Administration of Medical Devices.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A.2900 Automated urinalysis system
Import Information
QMS/QSD;; 輸入
Dates and status
Registration Date
Jan 17, 2018
Expiry Date
Jan 17, 2023
Cancellation Date
Sep 30, 2021
Cancellation information
Status
Logged out
Reason
轉為登錄字號
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About this record

Access comprehensive regulatory information for ICEN 100 Urine Chemistry Analyzer (Unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 15e96fd8dfdd4483415f27e61923e55c and manufactured by IRIS DIAGNOSTICS, A DIVISION OF IRIS INTERNATIONAL, INC.. The authorized representative in Taiwan is BECKMAN COULTER TAIWAN INC., TAIWAN BRANCH (U.S.A.).

This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including IRIS DIAGNOSTICS, A DIVISION OF IRIS INTERNATIONAL, INC., IRIS DIAGNOSTICS, and 2 recent registrations in the same category. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.

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